The health care industry is an extraordinarily large and information intensive sector of the United State's economy. Many different participants in the health care industry constantly rely on a vast amount of data-intensive information. Physicians, for example, rely on information to make decisions which influence a disproportionately large portion of all spending in the health care sector. Over the years, a robust health care information system (HIS) industry has developed, in part to provide physicians with the data they need to make informed-decisions. Despite the growth of the health care sector in general and the HIS industry in particular, an information system infrastructure which satisfies the needs and wants of physicians has not yet been developed.
Numerous problems exist with today's health care information systems. A few of the more important parties will now be examined in terms of the problems they are facing.
Health Care Insurance
Health care insurance is an enormous industry, typically focused on generating revenue through increased contracts and by controlling costs through the management of claims reimbursement. One of the larger components of the insurance cost structure is derived from prescription medication, the cost of which rises significantly each year. The majority of the insurance industry has attempted to lower these costs by outsourcing the management of prescription medication reimbursement to intermediaries known as Pharmacy Benefit Management organizations (PBMs).
PBMs are companies who track all prescriptions written by physicians in a health plan the physician has contracted with. They administer prescription drug claims, establish formularies, track physician prescribing patterns, provide education to improve their efficiency and cost effectiveness, and provide disease management programs. The main function of PBMs, however, is to control the cost of prescription drugs.
To lower costs of prescription drugs, PBMs negotiate prices on medications with pharmaceutical companies. They then attempt to determine the price-performance profile of all the drugs on the market. As different pharmaceutical companies negotiate different prices, these profiles will vary according to payer. At the end of this evaluation, the PBMs create a “formulary” which is a list of medications that the PBM will cover. A formulary may contain either brand name drugs or generic drugs. Generic drugs have the same active ingredients, strength, and dosage form and are therapeutically equivalent to their brand-name counterparts. Many health plans revise their formulary lists frequently, resulting in changes that the patient and his or her physician may not be aware of. Patients often learn of the change only when their pharmacist informs them, or when they collect their prescription medication and notice a difference, which leaves insufficient time to appeal the change. Some health plans provide physicians with a monthly drug budget, financially penalizing physicians if they go over budget and rewarding them if they stay below budget. This is commonly referred to as “risk sharing” or “risk pooling”. Most medication on the market has a status within the formulary. The status of any medication may therefore be preferred, approved, approved with prior authorization by the payer, available only as a generic, or not approved. Medications that are on-formulary have therefore been approved by a particular health plan, and medications that are off formulary have not been approved.
The PBMs communicate this formulary to physicians by mailing them binders containing formulary information every three to six months. Each health plan has its own formulary so a physician may receive as many as 100 different booklets, though 20-30 is more typical. The content of the formulary is reinforced by a PBM “detail” force of PBM representatives who visit the physician periodically. Despite the above, physicians typically have a low compliance with these formularies.
PBMs typically enforce the formulary at the pharmacy. When a patient submits a prescription, the pharmacist enters an on-line system which checks the medication against a specific health plan's formulary. If the medication is on-formulary, it is dispensed, generally with a co-payment by the patient. If it is off-formulary and a generic substitute has not been authorized, the patient either pays for the medication himself or the pharmacist calls the doctor's office to request an alternative. This process can be time consuming, requiring the patient to either wait in the pharmacy or return at a later time.
PBMs exist to manage and enforce these formularies. PBMs are therefore constantly seeking ways to increase physician compliance without incurring significant financial and/or political costs. Mailing the binders and using detail forces are costly. Rejecting prescriptions at the pharmacy level generates significant animosity among the physician community and does little to encourage higher compliance with the formularies. Prescribing off-formulary medication and the lack of communication between PBM's and physicians results in higher transaction costs for the patient.
PBMs, consequently, need a solution at the point-of-care to help reduce their cost of operations and minimize the burden their formularies impose on physicians and patients.
Furthermore, patients referred to specialists by physicians, can often only see specialists specific to their particular health plan. Physicians typically have difficulty in determining which specialists are on a particular health plan, particularly specialists in the patients' geographical area.
Some health plans also incorporate an exacting list of billing codes for different medical procedures. When submitting a claim on behalf of a patient, a physician will typically need to submit these codes in order to be paid. Some physicians have prepared a form listing the more common procedures, next to which they can check a box, to facilitate the task of submitting claims. Unfortunately not all types of procedures can be listed, which leads to the physician checking a box which is closest to the completed procedure. This leads to inaccuracies and non compliance with the specific health plans rules. The most common systems of billing codes are ICD9, CPT4 and E&M. ICD9 is an international classification of disease that assigns a unique number to each different diagnosis. CPT4 codes are procedure codes, so for example, a left main artery bypass would have a certain code associated with it. E&M codes are similar to CPT4 codes. Presently physicians use a form called a “superbill” which lists approximately 90 different codes (charge capture). As there are thousands of codes, and only so many on the superbill, a physician tends to be non-specific when completing the form. If more specificity could be provided, physicians may be able to charge more accurately.
Certain health plans have also adopted specific clinical protocols that physicians contracted to the plan must follow. There are typically vast amounts of clinical protocols contained in books which the physician does not always have the time to consult. A technical solution at the point-of-care could alleviate this problem.
Physicians
Physicians are under increasing pressure to see more patients per day. Moreover, they are subject to an ever-increasing number of rules which require a significant amount of time to comply with.
The above-mentioned formulary represents one of these restrictions. Currently, physicians have one copy of each formulary for each health plan with which their practice contracts. Typically, a high-volume physician will contract with 20-30 plans, depending on the region in which he works, so there will be 20-30 formulary booklets in a common area of his or her office. It is simply impossible for the physician to remember which medications are on which plans. Consequently, when a physician writes a prescription, he has two choices. He can leave the patient in the exam room for about two minutes while he looks up the formulary status of the drug he wishes to use and select an alternative if necessary or he can simply prescribe without knowing the medication's formulary status. In the latter scenario, there is a significant chance that the medication will be off-formulary and his office will receive a call from the pharmacy. The staff will have to pull the patient's chart at an additional cost and ask the physicians to authorize the substitution. The patient, meanwhile, must wait at the pharmacy until the substitution is made. If the physician's compliance rate is low enough and he operates under a risk sharing contract with the insurance company for pharmaceutical costs, failure to comply can actually carry a direct financial penalty. In either scenario, the physician has spent a fair amount of time complying with insurance rules and not treating patients. It is estimated that as much as 20% of all prescriptions are still written off-formulary.
The problem of complying with formularies has grown worse in recent years due to the proliferation of contracted health plans and the fact that formularies are becoming increasingly restrictive.
The problem physicians face with formularies can be extended to the higher order problem they face of inadequate access to information in general. This problem is well-known and ranges from missing charts to inaccessible lab reports and unknown medical records. The results are increased incidence of disease and mortality, higher costs, and wasted resources. Recent studies show that approximately 100 000 deaths a year occur due to medication errors. Physicians may also have poor access to up-to-date clinical information and/or drug prices. Clinical information may include pharmacopeia which describes drugs, chemicals, and medicinal preparations and is typically issued by officially recognized authorities to serve as a standard. Furthermore, the Food and Drug Administration (FDA) has introduced a faster process for approving drugs, leading to a increase in the number of drugs available each year.
Information technology has been employed to address these problems with limited success. A problem encountered has been getting the physician, the key decision-maker, to use such technologies.
Every day, hundreds of thousands of physicians treat millions of patients using a combination of experience, judgment and data. When this data is missing or inadequate, treatment is impaired. The impact, which depends on the nature of the information and the condition of the patient, can for example include: patients suffering complications, including death, from contraindicated medications; doctors spending significant time looking for information and making inappropriate clinical decisions when on call; and insurers incurring the cost of extra nights of expensive hospitalization due to “missing” lab results.
The applications developed for physicians to date have been excessively ambitious, requiring the doctor to change his or her practice patterns to conform to new technology. Such applications have also been cumbersome, inefficient, and rigid, slowing the physician down at a time when he or she is being forced to see more patients per hour. Moreover, most applications have been designed for desktop or tablet computers. This fails to recognize that physicians are not desk-bound and do not have wireless systems in their offices. The inadequacies of these applications and their hardware platforms has restricted their use by physicians which, in turn, has prevented the population of clinical databases which could be used for clinical decision support.
Access to electronic databases containing medical information has typically been a complicated process at an added expense to the physician, a cost which is ultimately passed on to the patient.
Furthermore, physicians have typically not obtained much training in the areas of business and practice management. Information and advice in these areas would therefore be appreciated by many practicing physicians.
Pharmaceutical Companies
A large portion of pharmaceutical companies revenues are derived from prescriptions written by physicians. Physicians who prescribe more medication are of heightened interest to the pharmaceutical industry because they generate a disproportionately large percentage of a pharmaceutical company's revenue.
As industry revenues have grown, so has the proliferation of new products. While there has been much innovation, many of these new medications are little different from other drugs in the same therapeutic category. The pharmaceutical industry is highly leveraged operationally. Most research and development expenditures are fixed and sunk. Manufacturing, however, has minimal fixed costs. The result is that pharmaceutical companies operate with large gross margins and therefore any incremental sale affects their profits. The result is an intense pressure to increase sales and to capture market share. Consequently, pharmaceutical companies spend an extraordinary amount of money on marketing, particularly to physicians, to accentuate the minimal differences between medications.
In health care, the end user has little influence on the purchasing decision and drug selection remains to a large extent the choice of the physician. Consequently, pharmaceutical companies spend an inordinate amount of money trying to influence the behavior of physicians. Pharmaceutical sales forces comprise a large component of this spending. The problem for pharmaceutical companies is that their sales forces are not able to spend as much time with the high-value, top percentage of physicians as they would like; instead they visit less valuable physicians who have fewer pharmaceutical company representatives calling on them and more time to spend with each. Pharmaceutical companies therefore need a means for giving their representatives access to these high-value physicians.
Furthermore, insurance companies create a barrier for the pharmaceutical companies through their formularies. These lists of approved medications are extremely difficult to memorize. Often, given the similarity between drugs of a therapeutic class, physicians simply prescribe the drug which appears to be on most formularies to minimize the chance of their guess being incorrect.
In addition, pharmaceutical companies typically also have a poor and ineffective Internet presence which does not attract physicians to their Web sites to, for example, familiarize themselves with current developments.
Contract Research Organizations
Contract Research Organizations (CROs) conduct clinical trials on new and existing medications and devices to gain more information about them. Development of new drugs is a long and complex process. Prior to any exposure to humans, a drug must be shown to be safe and non-toxic in extensive animal studies. Once this safety is proven, the drug is first given to normal, healthy volunteers (Phase I trials). Once safety is shown in healthy volunteers, the drug is given to patients with the specific medical conditions that the drug was designed to treat (Phase II & III studies). If the drug appears safe and effective, then application is made to the regulatory authorities to grant approval to market the medication to the public. Often, once the medication is on the market, additional studies are performed. These studies are called Phase IV studies.
CROs often have difficulty acquiring principal investigators (Medical Doctors) to undertake clinical trials of new drugs on their patients for Phases I to IV. Furthermore Contract Research Organizations may have difficulty enrolling patients into their clinical trials.
A technology that could help alleviate these problems would accelerate drug approval and ultimately lower drug costs.
Managed Care Organizations
A managed care organization is a health care provider (or group of medical service providers) who contracts to provide a wide variety of healthcare services to enrolled members through participating providers. These organizations typically do not have a means of communicating with physicians to, for example, inform them of changes in the industry. Managed Care Organizations also have difficulty enforcing compliance with their rules and regulations.
A widespread means of communicating with physicians and assisting their compliance with the rules could reduce overall health care costs.
Healthcare Information Systems Developers
Healthcare information systems companies (HIS) sell complex solutions to the health care industry. Some of their applications are for nurses, others for administrators, and still others for physicians. Physicians are particularly influential, even though they do not use these applications as much as others, and applications supplied to physicians are currently not widespread. The various platforms which currently exist for supplying physicians with different types of information do not aggregate a multitude of healthcare information. In order to access a large number of healthcare professionals, healthcare information developers need to sell their product to an Integrated Delivery Network of doctors, hospitals and clinics (IDNs). There is no current effective means for supplying these applications directly to physicians on a wide scale basis.
Medical Web Sites
Another means of supplying physicians with healthcare information is via healthcare dedicated Web sites on the Internet. Typically however such sites experience low Web traffic with physicians. Studies have shown that non-medical Web sites also experience low Web traffic with valuable physicians.
The present invention attempts to address the above-mentioned problems which have not significantly been dealt with by the health care or information technology industries.
American Medical Association
The American Medical Association's ethical opinion 8.061 deals with “Gifts to Physicians from Industry”. Many gifts given to physicians by companies in the pharmaceutical, device, and medical equipment industries serve an important and socially beneficial function. However, any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Furthermore, no gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician's prescribing practices. Therefore gifts which influence a physician's prescribing practices may be unethical. A need therefore exists for an outside party, not dictated to by industry, to supply up-to-date information to physicians.
In order for new technology to be accepted by physicians, the technology utilized should be mobile, intuitive, and fast, with little or no training required. The system should fit the physician's workflow and not require physicians to leave the examination room or otherwise disrupt their interaction with patients. There should be little or no data entry required, simple point-and-click navigation, rapid response times, and one-touch “transparent” data updates from Web-accessible desktops. The invention should improve patient care, be easy for the physician to use, and be provided to the physician at no expense. It should also influence the existing and developing infrastructure and include the major industry participants in order to accelerate implementation and gain support.